House Bill 121

AN ACT TO BRING FORWARD SECTIONS 43-13-501 THROUGH 43-13-509,
MISSISSIPPI CODE OF 1972, WHICH PROVIDE FOR A DRUG REPOSITORY PROGRAM FOR
DONATED DRUGS, FOR THE PURPOSE OF AMENDMENT; AND FOR RELATED PURPOSES.

43-13-501.
As used in Sections 43-13-501 through 43-13-509, the following terms
have the following meanings, unless the context requires otherwise:

(a) "Board" means the State Board of
Pharmacy.

(b)
"Health care facility" means any of the following:

(i) A hospital as defined under Section 41-9-3;

(ii) An institution for the aged or infirm as defined in Section 43-11-1;

(iii) A hospice as defined in Section 41-85-3;

(c)
"Hospital" has the meaning as defined in Section 41-9-3.

(d)
"Nonprofit clinic" means a charitable nonprofit corporation
organized and operated under Section 79-11-101 et seq., or any charitable
organization not organized and not operated for profit, that provides health
care services to indigent and uninsured persons. "Nonprofit clinic" does not include a health care
facility as defined in this section or a facility that is operated for profit.

(e)
"Pharmacy" has the meaning as defined under Section 73-21-73.

(f)
"Prescription drug" means any drug to which the following
applies:

(i) Under the federal Food, Drug, and Cosmetic Act, as amended (21
USCS Section 301), the drug is required to bear a label containing the legend,
"Caution: Federal law prohibits
dispensing without prescription" or "Caution: Federal law restricts this drug to be used
by or on the order of a licensed veterinarian" or any similar restrictive
statement, or the drug may be dispensed only upon a prescription.

(ii) Under the Uniform Controlled Substances Law, (Section 41-29-101
et seq.), the drug may be dispensed only upon a prescription.

43-13-503.
(1) Not later than January 1,
2005, the State Board of Pharmacy and the State Department of Health jointly
shall establish a plan for a drug repository program to accept and dispense
prescription drugs donated for the purpose of being dispensed to individuals
who meet the eligibility standards established in the rules adopted by the
board under Section 43-13-509. The plan
shall be submitted to the Chairmen of the Public Health and Welfare Committees
of the Mississippi House of Representatives and Senate for their review. Under the drug repository program:

(a)
Only drugs in their original sealed and tamper-evident packaging may be
accepted and dispensed.

(b)
The packaging must be unopened, except that drugs packaged in single
unit doses may be accepted and dispensed when the outside packaging is opened
if the single unit dose packaging is undisturbed.

(c)
The drugs must have been properly stored such that the integrity of the
medicine remains intact.

(d)
A drug shall not be accepted or dispensed if there is reason to believe
that it is adulterated as described in Section 75-29-3.

(e)
Subject to the limitation specified in this subsection, unused drugs
dispensed for the purposes of the Medicaid program may be accepted and dispensed.

(2)
Nothing in subsection (1) of this section shall be construed as
prohibiting a pharmacy from accepting drugs that are not eligible to be
dispensed under the drug repository program, for the proper disposal of those
drugs.

(3)
The drug repository program shall be fully implemented not later than
July 1, 2005.

43-13-505.
(1) Any person, including a drug
manufacturer, health care facility or government entity may donate prescription
drugs to the drug repository program.
The drugs must be donated at a pharmacy, hospital, or nonprofit clinic
that participates in the drug repository program under the criteria for participation
established in the rules adopted by the board under Section 43-13-509.

(2)
A pharmacy, hospital, or nonprofit clinic that participates in the drug
repository program shall dispense drugs donated under this section to
individuals who meet the eligibility standards established in the rules adopted
by the board under Section 43-13-509, or to other government entities and
nonprofit private entities to be dispensed to individuals who meet the
eligibility standards. A drug may be
dispensed only pursuant to a prescription issued by a licensed practitioner as
defined in Section 73-21-73. A
pharmacy, hospital, or nonprofit clinic that accepts donated drugs shall comply
with all applicable federal laws and laws of this state dealing with storage
and distribution of dangerous drugs, and shall inspect all drugs before
dispensing them to determine that they are not adulterated. The pharmacy, hospital, or nonprofit clinic
may charge individuals receiving donated drugs a handling fee established in
accordance with the rules adopted by the board under Sections 43-13-501 through
43-13-509. Drugs donated to the
repository may not be resold.

(2)
The State Board of Pharmacy; the State Department of Health; the
Division of Medicaid; any person, including a drug manufacturer, or health care
facility or government entity that donates drugs to the repository program; any
pharmacy, hospital, nonprofit clinic or health care professional that accepts
or dispenses drugs under the program; and any pharmacy, hospital, or nonprofit
clinic that employs a health care professional who accepts or dispenses drugs
under the program, shall not be subject to any of the following for matters
related to donating, accepting, or dispensing drugs under the program: criminal prosecution; liability in tort or
other civil action or professional disciplinary action.

A drug manufacturer shall not, be subject
to criminal prosecution or liability in tort or other civil action for matters
related to the donation, acceptance, or dispensing of a drug manufactured by
the drug manufacturer that is donated by any person, health care facility or
government entity under the program, including, but not limited to, liability
for failure to transfer or communicate product or consumer information, or for
improper storage or for the expiration date of the donated drug.

43-13-509.
(1) Not later than January 1,
2005, the State Board of Pharmacy, in consultation with the State Department of
Health, shall adopt rules, in accordance with the Administrative Procedures Law
(Section 25-43-1 et seq.), governing the drug repository program that establish
all of the following:

(a)
Eligibility criteria for pharmacies, hospitals and nonprofit clinics to
receive and dispense donated drugs under the program;

(c)
Standards and procedures for inspecting donated drugs to determine that
the original unit dose packaging is sealed and tamper-evident and that the
drugs are unadulterated, safe and suitable for dispensing;

(d)
Eligibility standards based on economic need for individuals to receive
drugs;

(e)
A means, such as an identification card, by which an individual who is
eligible to receive donated drugs may demonstrate eligibility to the pharmacy, hospital,
or nonprofit clinic dispensing the drugs;

(f)
A form that an individual receiving a drug from the repository must sign
before receiving the drug to confirm that the individual understands the
immunity provisions of the program, and waiving all right to sue any individual
or entity involved in the program;

(g)
A formula to determine the amount of a handling fee that pharmacies,
hospitals and nonprofit clinics may charge to drug recipients to cover
restocking and dispensing costs;

(h)
In addition, for drugs donated to the repository by individuals:

(i) A list of drugs, arranged either by category or by individual
drug, that the repository will accept from individuals;

(ii) A list of drugs, arranged either by category or by individual
drug, that the repository will not accept from individuals. The list must include a statement as to why
the drug is ineligible for donation; and

(iii) A form each donor must sign stating that the donor is the owner
of the drugs and intends to voluntarily donate them to the repository;

(i)
In addition, for drugs donated to the repository by health care
facilities or government entities:

(i) A list of drugs, arranged either by category or by individual
drug, that the repository will accept from health care facilities or government
entities; and

(ii) A list of drugs, arranged either by category or by individual
drug, that the repository will not accept from health care facilities or
government entities. The list must
include a statement as to why the drug is ineligible for donation; and

(j)
Any other standards and procedures the board considers appropriate.

(2)
The provisions of paragraphs (h)(ii) and (i)(ii) of subsection (1) of
this section shall not be construed as prohibiting a pharmacy from accepting
drugs that are not eligible to be dispensed under the drug repository program,
for the proper disposal of those drugs.

SECTION
6. This act shall take effect and
be in force from and after July 1, 2007.